MAUDE Adverse Event Report: HTL-STREFA S.A. TECHLITE; PEN NEEDLE

Model Number	32G X 6MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer contols the force removal pen needles (for cap) from pen.No special capa.
Event or Problem Description
Customer is stating that over the course of time she found defective needles in her techlite pen needle product.She uses humalog kwik pens.She states that she is finding dull needles that will not go through her skin and some are broken or crooked.

• Brand Name: TECHLITE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; 95-03 5; PL 95-035
• MDR Report Key: 9537456
• Report Number: 9613304-2019-00088
• Device Sequence Number: 19403890
• Product Code: FMI
• UDI-Device Identifier: 10015482236325
• UDI-Public: (01)10015482236325(17)231201(10)Y46ZP5
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 12/01/2023
• Device Model Number: 32G X 6MM
• Device Catalogue Number: 8648
• Device Lot Number: Y46ZP5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1